Israeli company under the spotlight for ‘Aids cure’ claims

Claims from an Israeli company to have successfully trialled its ‘Aids cure’ in Uganda, which has caused a storm of interest on social media, this week came under scrutiny in a Bhekisisa report.

Fake news about HIV cures gives false hope to those living with HIV and even threatens to reverse some of the good work currently being done in the battle against the virus, writes Sanele Ngcobo, a clinical associate and PhD candidate in family medicine at the University of Pretoria in a Bhekisisa report.

Ngcobo writes: “When there are reports of possible HIV cures, most people think of an immediate solution without clearly understanding the journey of medication from lab to shelf. When Bhekisisa asked Israeli-based Zion Medical to see the peer-reviewed research to back up claims of a successful first clinical trial for what they called a potential HIV cure, the drug company said a paper ‘was currently in the works’.

“When bad science makes the headlines or Twitter, there are real consequences. One tweet announcing Zion Medical’s statement by a popular parody account was re-tweeted 4,000 times and liked by more than 6,000 Twitter users. A long debate followed after this, mostly dominated by messages congratulating the company on finding the ‘cure’.

“Statements like ‘Relief to those infected. They will get cured’ appeared soon after.”

Ngcobo writes: “We know that when, for instance, healers falsely claim to be able to cure HIV, people who believe this may stop taking antiretroviral (ARV) treatment. A 2014 study tracked about 400 patients in rural Tanzania who fell for an HIV cure hoax. Of those who actually sought out the local healer at the centre of this scam, ARV adherence dropped significantly albeit for a short time.

“Meanwhile, the firm’s statement claimed that most – not all – of nine patients who received the drug saw ‘a significant reduction of the viral load of up to 90%’ within the first four weeks.

“Viral load is the amount of HIV in your blood. This kind of reduction is not new and has been described with many antiretroviral (ARV) medications. We already know that taking commonly available antiretroviral (ARV) medication correctly every day can lower a person’s viral load to very low levels and when this happens, that’s called viral suppression.

“Zion Medical’s ‘trial’ was carried out at Dr Ronald Bata Memorial Hospital in Entebbe, Uganda, the company says in its release. There is no such trial registered in Entebbe, according to a search of the site ClinicalTrials.gov. One of the largest databases of its kind, the site is compiled by the US government’s National Library of Medicine based on information provided by the organisations and institutions that sponsor and sponsor and implement studies.”

Ngcobo writes that even a cursory glance through the supposed methodology of the study is worrying. The statement seems to describe a study done in two, short parts several weeks apart and neglects to mention how many people participated in total in the experiment, also known as a sample size. He says knowing how many people are part of a study – and how they were selected – offers essential clues to readers and scientists about how much one should trust a study’s results.

Ngcobo writes: “Questions do not end there. The statement goes on to describe how some patients were given the common ARV Aluvia while others received Aluvia and Zion’s experimental drug twice a week.

“Aluvia itself is a combination of two ARVs, lopinavir and ritonavir. HIV treatment is always prescribed as a course of three drugs to help prevent resistance. It is important to note that prescribing Aluvia monotherapy, in other words, so use as a single drug – and not in combination with at least two other ARVs – is not an appropriate standard of care.

“No safety data were reported so one can also not conclude that Zion Medical’s proposed treatment is safe and well-tolerated.”

“Knowing how drugs are made and tested can help us sort the bad science from the good. All drugs have to go through a rigorous scientific process before they can be licenced as safe and suitable for patient use. This usually happens in six sequential steps of medicine development. The first phase is called ‘pre-discovery’, and this is mostly a desktop review of the literature. Next, scientists get to work in the laboratory, testing out the chemical compounds that could – after almost a decade of testing – finally make it into a new drug. This second phase alone lasts about four to five years.

“Once researchers think they might be onto something, that’s when pre-clinical testing happens. Here, researchers will use computer models, vials or Petri dishes of cells and animals to see whether experimental drugs work and are safe.

“Next, novel drugs move to Phase 1 clinical trials in which the drug is tested in about 10 to 100 healthy people to see if it’s safe to use in people – tack on another seven years for this stage of development.

“In phase II clinical trials, about 100 to 500 patients who actually have the disease that the drug is meant to treat gulp down doses – this number jumps to between 1 000 to 5 000 such patients in the next stage, phase III clinical trials. Phase III trials generate data about safety, efficacy and the overall risk-benefit ratio of the medicine.”

Ngcobo writes that a 2010 study estimated that in total, all these steps take can more than nine years.

He writes: “Senior account specialist Philipp Jago with the New York-based public relations firm Spector & Associates, announced that Zion Medical was announcing the results of a Phase 2a study this week. Even if Zion’s drug was indeed as effective as its eight-paragraph press statement boasted, it will still take many years before it could be available on the shelf.”

Ngcobo writes that the above critique is just an example to demonstrate how little we really know about these results. Even articles debunking the research included the word “cure” in the headline: “ HIV cure ‘smacks of quackery’ – scientist”. He says a large number of people just read the headlines and not the actual article. He points out that the language used by News24 in the title is sensationalist and created the impression that a cure does exist. Even the material released by Zion Medical refers to a “potential cure”.

Meanwhile, he writes, the Health Department has not issued any response regarding this very important issue. While the government can’t be expected to respond to all fake news, this case has grabbed the attention of the nation. Ngcobo writes that it is therefore crucial for the government, in particular, the health department, to come up with a strategy of combating this issue.

Zion Medical respondsBhekisisaput the following questions to Zion Medical regarding the press release and as right of reply to the above comment piece. The company’s answers appear below:Why did the company choose to announce the results of its trial before peer-reviewed publication?
“Peer-reviewed publication of the results is being done parallel to this announcement. The company felt the results were encouraging enough to share them with the public.”

You described the study as a Phase 2a. The press release says it was a Phase 1/2a – what does that mean and how many people were involved?
“The study was always described as Phase 1/2a, which means that the main purpose was to show safety, tolerability (as Phase 1 should) and preliminary efficacy with a small number of HIV patients (thus phase 2a). Fortunately, we were able to show this efficacy, which will need to be reaffirmed in a larger Phase 2 study.”

The statement makes reference to nine patients, which is far below the usual 100 to 500 people using included in a Phase 2, researchers say. How would you respond?
“As described above. Phase 2a is usually defined as a small study with a small number of patients, just like our study. We agree that Phase 2b and 3, once initial safety and tolerability has been proven, is usually performed on a larger number of patients. Something we indeed intend to do in the coming months.”

With what regulatory authority is this trial registered with? Have you registered this trial with ClinicalTrials.gov?
Future studies Phase 2b and 3 will, of course, be registered. This study was not registered (yet) in clinicaltrails.gov as it was a preliminary (phase 1/2a) study.

The statement says that in Phase II (part II and not phase II) of the study, patients on Aluvia were compared to patients on Aluvia with a twice-weekly dose of Gammora. Aluvia is a two-drug combo. How do you justify giving patients dual therapy when triple therapy is the gold standard in HIV care around the world?
“The statement says that this was the case in part II of Phase 2a, not for the entirety of Phase 2a. Patients on Aluvia were a control group without Gammora. According to ethical guidelines in respect to the treatment of HIV, and because there is this gold standard, the study could only last a few weeks. This is also the reason for the short-term nature of our study, with only a 4-5 week duration of Part II.”

Do you have approval from the national ministry of health in Uganda for this study?
“Yes, as well as Helsinki approval.”*

*[Editor’s note: The World Medical Association’s internationally recognised Declaration of Helsinki sets out ethical principles for medical research involving human subjects. It is a document and not an approval by any regulatory body.]

Zion Medical has issued a further statement on Twitter making it clear that more trials will be needed, and their official results will need to be published and peer-reviewed. Health24 reports that since the company made the announcement on 31 October, there has been a wave of excitement on social media in particular, with people clamouring for more information on the “potential cure”.

The report says in a statement at the time, Zion Medical announced the results of the first clinical trial of its HIV-drug Gammora, which, the company said, eliminated up to 99% of the HI virus within four weeks of treatment. Nine HIV-infected patients took part in “Part I and II” of the trial, at Dr Ronald Bata Memorial Hospital in Entebbe, over 10 weeks.

But, the report says, the company has moved to temper expectations, saying on Twitter: “We want to thank everyone for their interest in the promising results of our first clinical trial. Like you, we are hopeful that #Gammora may one day offer those affected by #HIV a viable path to ridding themselves of infection. Much work remains in this mission including additional trials, publication of results and the steps required to make #Gammora commercially available. We are not there yet, but we are a step closer, hopeful – and committed to keeping you informed of our progress.” The company also acknowledged that the official results should be peer-reviewed in a scientific journal, which it hopes to have done in early 2019.

Professor Adrian Puren, head of the HIV surveillance and sero-molecular diagnostic section at the National Institute for Communicable Diseases, is quoted in the report as saying that there is a lengthy process that needs to be followed, before being bold enough to call the drug a potential cure. “You would need to go through several stages to prove something like this. Doing the research, gathering the evidence and building up all that’s required to find some potential is important.

“There are different phases that you would need to go through as well. You may need to do an animal trial, then a small human trial – the process is complex and you may need to start out really small and run several tests in order to determine that the drugs aren’t toxic and that there aren’t any harmful side effects. You would also need to test the efficacy of the medication at various stages, going through the different phases of trials. At some stage you would also need to run randomised tests so that you eliminate biases from the research and really make sure people aren’t being harmed.

“Going through something like this is not easy. It is highly complex, needs to be detailed and it’s quite expensive. If I were going to look into this drug, I would want to see the published literature and be able to trace everything back to the authors, knowing that everything has been reviewed. Once all of the research has been done, it’s been reviewed and it is run through all the regulatory authorities, various ethics boards, and sufficiently scrutinised, then a company will be able to make a statement like that. And when they do make announcements like this, they usually do it at big conferences,” said Puren.

The Health Department’s deputy director general for HIV/Aids, TB and Maternal, Child and Women’s Health, Dr Yogan Pillay, added, “As far as we are aware, there is no published clinical trials on this. Unless this is published in peer reviewed journals and the World Health Organisation approved this drug, we cannot take this claim seriously.”

The report says a prominent SA HIV scientist had earlier slammed the “cure”, which was widely being punted on social media, as smacking of “quackery”. “The HIV world has seen quackery in different forms for decades – sadly this smacks of more of it,” Professor Francois Venter from the University of Witwatersrand’s Reproductive Health and HIV Institute, is quoted as saying.

He said that saying the drug is a potential cure with no side-effects are “over-the-top biological claims that appear in public before the formal literature (is published) and should be viewed with deep scepticism”.

“I looked at the press report and the unsophisticated company website, and even if you believe their claims, they are many years away from testing them,” said Venter.

The report says Zion Medical is a relatively new company, established in 2014. According to the company website, it develops Aids and cancer curing products based on peptides derived from HIV and targeted lentivirus particles. It lists its partners as The Hebrew University of Jerusalem, Mount Sinai Hospital in New York and the Tel-Aviv Sourasky Medical Centre, among others.

The report says all attempts to contact Zion Medical directly for further comment have so far been unsuccessful – all forms of electronic mails have been undeliverable due to an invalid email address and all telephone calls go unanswered.

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